The IMMAGE Immunochemistry System C-reactive protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry.

Device Description

The IMMAGE Immunochemistry System C-Reactive Protein (CRP) reagent, in conjunction with Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE® Immunochemistry System.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for method comparison, stability, linearity, or imprecision. Instead, it indicates that the provided data "supports a finding of substantial equivalence to chemistry test systems already in commercial distribution." The reported performance data for imprecision is presented below:

Performance Metric	Acceptance Criteria (Not explicitly stated with thresholds, but implied to be comparable to predicate)	Reported Device Performance (IMMAGE System CRP Reagent)
Within-Run Imprecision	(Implied to be acceptable for substantial equivalence)
Level 1		Mean: 0.35 mg/dL, SD: 0.039 mg/dL, %CV: 11.1
Level 2		Mean: 4.95 mg/dL, SD: 0.129 mg/dL, %CV: 2.6
Level 3		Mean: 6.69 mg/dL, SD: 0.236 mg/dL, %CV: 3.5
Total Imprecision	(Implied to be acceptable for substantial equivalence)
Level 1		Mean: 0.35 mg/dL, SD: 0.043 mg/dL, %CV: 12.1
Level 2		Mean: 4.95 mg/dL, SD: 0.149 mg/dL, %CV: 3.0
Level 3		Mean: 6.69 mg/dL, SD: 0.266 mg/dL, %CV: 4.0
Method Comparison	(Implied to show substantial equivalence to predicate)	(Results are mentioned as part of the study but not detailed in this section.)
Stability	(Implied to be acceptable for substantial equivalence, with 30 days once opened)	(Results are mentioned as part of the study but not detailed in this section.)
Linearity	(Implied to be acceptable for substantial equivalence)	(Results are mentioned as part of the study but not detailed in this section.)

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set:
- For the imprecision study, N=80 samples were used at each of the three levels (Level 1, Level 2, Level 3) for both within-run and total imprecision calculations.
- The sample size for the method comparison, stability, and linearity studies is not explicitly stated in the provided text.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a submission to the FDA in the US by Beckman Coulter, Inc., based in California, so it's likely the studies were conducted in the US, but this is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

This device is an in-vitro diagnostic (IVD) reagent for quantitative determination of a biomarker (C-reactive protein). The "ground truth" for such devices typically refers to the true concentration of the analyte in a sample. Expert consensus or human interpretation (like radiologists) is not relevant in this context.
The ground truth would have been established through a reference method or validated assays/calibrators, often with traceable standards. The document does not specify how the ground truth was established for the samples used in the imprecision, linearity, or method comparison studies. It mentions the use of "Calibrator 5 Plus" in the intended use, implying a calibrated system.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1) are usually relevant for studies involving human interpretation or subjective assessments, often in areas like imaging.
For an IVD device like the CRP reagent, the "adjudication method" as typically understood in human-read studies is not applicable. The measurement is quantitative and objective, based on the instrument's reading.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or is not applicable here. This type of study involves multiple human readers assessing cases (e.g., medical images) to evaluate the impact of an AI algorithm on their performance.
The IMMAGE® Immunochemistry System CRP Reagent is an automated laboratory assay that quantifies a biomarker. It does not involve human readers interpreting cases in the same way an imaging AI might. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

6. Standalone (Algorithm-Only) Performance Study

Yes, the performance data presented (imprecision, method comparison, stability, linearity) represents the standalone performance of the IMMAGE® Immunochemistry System CRP Reagent in conjunction with the IMMAGE® Immunochemistry System.
This refers to the performance of the device itself (reagent + instrument) without human intervention in the result generation beyond operating the instrument according to instructions.

7. Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth used for the performance studies.
For quantitative IVD assays, ground truth is typically established through:
- Reference materials/calibrators: Samples with known, validated concentrations of the analyte.
- Validated reference methods: Using a method considered the gold standard for measuring CRP.
- Comparative methods: Often, a well-established predicate device's results are used as the comparative "truth" or reference for evaluating substantial equivalence, as indicated in the "Method Comparison Study Results" section.

8. Sample Size for the Training Set

The IMMAGE® Immunochemistry System CRP Reagent is a diagnostic reagent, likely based on well-established nephelometric principles and antibody-antigen reactions. It does not employ machine learning or artificial intelligence that would require a "training set" in the computational sense.
Therefore, there is no training set sample size mentioned or applicable in the context of this device.

9. How Ground Truth for the Training Set Was Established

As concluded in point 8, there is no "training set" for this type of chemical reagent and its associated measurement system.

Summary

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JUN 12 1998

BECKMAN

K981638

Summary of Safety & Effectiveness IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent

1.0 Submitted By:

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123

2.0 Date Submitted:

May 7, 1998

3.0 Device Name(s):

3.1 Proprietary Names
IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent

3.2 Classification Name

C-Reactive Protein immunological test system (21 CFR § 866.5270)

4.0 Predicate Device(s):

IMMAGE SystemReagent	Predicate	Manufacturer	DocketNumber
IMMAGE SystemC-Reactive Protein(CRP) Reagent	Behring N Latex CRP	Behring Diagnostics*	K962523

Behring Diagnostics (Westwood, MA)

5.0 Description:

6.0 Intended Use:

The IMMAGE® Immunochemistry System C-Reactive Protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry.

Beckman Instruments, Inc.

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Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary. A STATISTIC COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTI

	SIMILARITIES
IMMAGE SystemCRP Reagent	Intended Use	Same as BehringN Latex CRP
	Nephelometric methodology
	Use of Latex particletechnology
	DIFFERENCES
IMMAGE SystemCRP Reagent	Form of reagent	the IMMAGE CRP is liquid stablewhile Behring N Latex CRPreagent is lyophilized
	Antibody source	IMMAGE CRP uses goat whileBehring N Latex CRP uses rabbit.
	Stability	IMMAGE CRP is stable for 30days once opened, properly storedwhile Behring N Latex CRPreagent is stable for one weekfollowing reconstitution.

Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.

Method Comparison Study Results IMMAGE C-Reactive Protein (CRP) Reagent

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Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Level 1	0.35	0.039	11.1	80
Level 2	4.95	0.129	2.6	80
Level 3	6.69	0.236	3.5	80
Total Imprecision
Level 1	0.35	0.043	12.1	80
Level 2	4.95	0.149	3.0	80
Level 3	6.69	0.266	4.0	80

Estimated Improvision

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle.

JUN 1 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annette Hellie Senior Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 Brea, California 92822-8000

Re : K981638

IMMAGE® Immunochemistry System C-Reactive Protein Trade Name: (CRP) Reagent

Regulatory Class: II Product Code: DCK Dated: May 7, 1998 Received: May 8, 1998

Dear Ms. Hellie:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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Paqe 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page ___ of ]

510(k) Number (if known):

K9816638

Device Name: IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent

Indications for Use:

The IMMAGE Immunochemistry System C-reactive protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human Creactive protein concentrations in human serum and plasma samples by rate nephelometry.

Clinical Significance:

Measurement of C-reactive protein aids in evaluation of stress, trauma, infection, inflammation, and surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number	K981638
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Prescription Use	OR	Over-the-Counter Use
(per 21 CFR 801.109)		Optional Format 1-2-96

Regulation Number and Section

§ 866.5270 C-reactive protein immunological test system.

(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).